BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA POSTERIOR PACK W AFI & FF

    MDR report key: 3070437 · Received April 17, 2013

    Report

    Report Number
    1920664-2013-00092
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL COMPLETED. THE ASSEMBLY WAS RETURNED IN A LARGE RED BIOHAZARD BAG ALONG WITH THE (B)(4) PACK LABEL FROM LOT U9781. THE ASSEMBLY WAS ALL TANGLED AND WADDED UP TOGETHER. THERE WAS SOLUTION VISIBLE IN THE LINE AND COLLECTION CASSETTE. THE VITREOUS CUTTER TUBING HAD BEEN CUT OFF THE ASSEMBLY. THE 25GA CUTTER WAS LYING LOOSE IN BOTTOM OF THE BIOHAZARD BAG. THE TIP PROTECTOR WAS NOT RETURNED. THE CUTTER WAS BENT APPROX. 20-30 DEGREES. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLES IN THE SIDES OF THE CUTTER BODY. A FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CUT TUBING. THE CUSTOMER ALSO RETURNED EIGHT UNOPENED PACKS FROM LOT U9781. A FUNCTIONAL TEST WAS PERFORMED AND ALL EIGHT ASSEMBLIES HAD GOOD CLEAN CUTS AT VARIOUS CUT RATES AND ASPIRATED AS REQUIRED. A LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE STERILIZATION AND LOT HISTORY RECORDS COULD NOT BE REVIEWED. REPORT 2 OF 2. SEE REPORT #1920664-2013-00091.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE VITREOUS CUTTER STOPPED DURING THE PROCEDURE. THE SURGEON FELT HE WAS NOT GETTING THE CORRECT ASPIRATION. THE CUTTER WAS ON AND OFF; THEREFORE, HE HAD TO BACK OFF THE PEDAL TO RE-ENGAGE THE CUTTER. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165008 STELLARIS 25GA POSTERIOR PACK W AFI & FF HQC BAUSCH & LOMB, INC. BL5425 U9781

    Patients

    Seq Age Sex Outcome Treatment
    1